Anorexia NervosaAPANORNCT04817436
Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
A study testing physical activity program (APA) in people with Anorexia Nervosa, run by University Hospital, Rouen at 1 site in France.
Trial summary
Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- physical activity program (APA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2021to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Patient > 18 years
- Follow-up in the department of clinical Nutrition of Rouen
- BMI ≥15,0 and <18,5 kg/m²
- Diagnosis of anorexia nervosa according to DSM-V classification
Who cannot join
- Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension
- Patients with poor understanding of spoken or written French
- Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults
- Person subject to a safeguard of justice, guardianship or curatorship.
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.
- Conditions
- Anorexia Nervosa
- Being tested
- physical activity program (APA)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity program (APA)Other
adapted physical activity program (APA)
| Study group | Role | What they receive |
|---|---|---|
| Without adapted physical activity program (APA) | Active comparator | Not described Receives: Other: physical activity program (APA) |
| With adapted physical activity program (APA) | Experimental | Not described Receives: Other: physical activity program (APA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism
Variation of plasmatic kynurenin acid between V1 and V2 in patients undergoing APA during refeeding versus other patients (control group without APA)
Measured: 3 months
Secondary outcomes (5)
To evaluate the effects of adapated physical activity program on anthropometric data.
Anthropometric data
Measured: 3 months
To evaluate the involving of gut microbiota composition and diversity
gut microbiota analyses
Measured: 3 months
To evaluate the effects of adapated physical activity program on quality of life
Self-administered questionnaires assessing the quality of life
Measured: 3 months
To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation
Dosage of auto-antibodies against neuropeptides involved in food intake regulation using ELISA method (enzyme-linked immunosorbent assay)
Measured: 3 months
To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)
Mesaurement of fat and free mass
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start8 Sep 2021
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Why it stopped: Diffiulty in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817436
- Sponsor's protocol ID
- 2017/383/HP
- Acronym
- APANOR
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study
- ClinicalTrials.gov ID
- NCT04817436
- Acronym / sponsor ID
- APANOR / 2017/383/HP
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Diffiulty in enrolling patients
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without adapted physical activity program (APA) | Active comparator | Other: physical activity program (APA) |
| With adapted physical activity program (APA) | Experimental | Other: physical activity program (APA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Patient > 18 years
- Follow-up in the department of clinical Nutrition of Rouen
- BMI ≥15,0 and <18,5 kg/m²
- Diagnosis of anorexia nervosa according to DSM-V classification
Key exclusion criteria (5 listed)
- Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension
- Patients with poor understanding of spoken or written French
- Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults
- Person subject to a safeguard of justice, guardianship or curatorship.
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity program (APA)adapted physical activity program (APA) | Other | With adapted physical activity program (APA), Without adapted physical activity program (APA) |
Primary outcome
To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism
Time frame: 3 months
Variation of plasmatic kynurenin acid between V1 and V2 in patients undergoing APA during refeeding versus other patients (control group without APA)
5 secondary outcomes
To evaluate the effects of adapated physical activity program on anthropometric data.
Time frame: 3 months
To evaluate the involving of gut microbiota composition and diversity
Time frame: 3 months
To evaluate the effects of adapated physical activity program on quality of life
Time frame: 3 months
To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation
Time frame: 3 months
To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Diffiulty in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity program (APA) in people with Anorexia Nervosa, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Diffiulty in enrolling patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.